Method and Device to Inactivate and Kill Cells and Organisms that are Undesirable

ABSTRACT

A method, means, and apparatus to prevent and treat infections and disorders using germicidal light to inactivate and/or kill the organisms or cells that cause infections and other disorders. The method of treatment comprises irradiating the area to be treated using electromagnetic radiation of a germicidal nature. The method utilizes a previously unrecognized ability of germicidal light to penetrate the skin, nails, and other membranes sufficiently to successfully treat and prevent disorders. The electromagnetic radiation damages the organisms and cells that cause disorders such as skin and nail infections and renders them substantially incapable of reproducing. Without the ability to replicate the organism cannot continue to infest the skin and nails. The damage inflicted can also be sufficient to kill the organism outright. An infection is thereby prevented (if organisms are present, but infection has not yet begun), and the infection is cured if the infection already exists.

1 CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. application Ser. No.11/154,707, filed Jun. 17, 2005, which is a continuation in part of U.S.patent application Ser. No. 10/215,834, filed Aug. 9, 2002, now U.S.Pat. No. 6,960,201, which claims the benefit of U.S. ProvisionalApplication 60/355,088, filed Feb. 11, 2002, all of which areincorporated herein by reference. The application is also a continuationin part of U.S. application Ser. No. 11/185,791, filed Jul. 21, 2005,which is incorporated herein by reference. This application also claimsbenefit of U.S. Provisional Applications Ser. No. 60/792,331, filed Apr.17, 2006, Ser. No. 60/810,167, filed Jun. 2, 2006, and Ser. No.60/844,642, filed Sep. 15, 2006, each of which are incorporated hereinby reference.

BACKGROUND

Germicidal light has been used for many years to inactivate and killorganisms found in air and water and to sterilize surfaces. Ultravioletlight in the ‘C’ range of 240 nm to 280 nm (also called the “UVC range”)is recognized as the most germicidal of all light. However, due to itsshort wavelength, UVC does not penetrate substances very deeply. Forexample, the sun emits a large amount of UVC, however, no UVC reachesthe earth's surface because it is completely absorbed in the atmosphere.Literature on UVC notes that it cannot significantly penetrate anymedium besides air and relatively clean water due to its shortwavelength. This lack of penetration has prevented those skilled in theart from trying to use UVC to inactivate or kill organisms in tissue. Ithas also caused those skilled in the art to research forms of germicidallight other than UVC that may be more capable of penetrating tissue andother mediums.

2 SUMMARY AND OBJECTS AND ADVANTAGES OF THE INVENTION

The present invention, a method, means, and apparatus to prevent andtreat infections and disorders, uses germicidal light to inactivateand/or kill the organisms or cells that cause infections and otherdisorders. The method of treatment comprises irradiating the area to betreated using electromagnetic radiation of a germicidal nature. Themethod utilizes a previously unrecognized ability of germicidal light topenetrate the skin, nails, and other membranes sufficiently tosuccessfully treat and prevent disorders. Said electromagnetic radiationdamages the organisms and cells that cause disorders such as skin andnail infections and renders them substantially incapable of reproducing.Without the ability to replicate the organism cannot continue to infestthe skin and nails. The damage inflicted can also be sufficient to killthe organism outright. An infection is thereby prevented (if organismsare present, but infection has not yet begun), and the infection iscured if the infection already exists.

The method of the invention may thus include one or more of thefollowing steps: diagnosing an infection or potential infection;determining the location of the infection, especially in skin or nail;testing transmissivity of the tissue surrounding the location to light;calculating an amount of light necessary to achieve the proper dosage atthe infected area, especially a location beneath an amount of skin ornail; selecting a light source to be used; selecting a filter to filtera portion of the light; modifying the light to enhance itseffectiveness; directing the light to the appropriate area, such as byusing shields or light guides; supplementing the light treatment;applying treatment cycles; and repeating some or all of the steps asnecessary.

In some embodiments, the light source may be a narrowband light source.In some embodiments, the light source may be a broadband light source.In some embodiments, light may be modified by at least one of pulsing,combing light sources, filtering the light, modulating the light, andevaluating the energy of the light. In certain embodiments, light may bedirected to a particular area by a shield or light guide. In someembodiments, the method of the invention can be supplemented withadditional treatments including, but not limited to, antiobiotics,antibodies, and chemotherapeutic agents. In certain embodiments, lightmay be provided in treatment cycles, which include, but are not limitedto, applying multiple types of light sequentially, applying multipletypes of light in parallel, and applying light in periodic does.

In some embodiments, germicidal light can be used to inactivate and killundesirable cells in the treatment. The term “inactivate,” as usedthroughout, refers to rendering an organism incapable of reproducing. Apopulation of organisms is “substantially incapable of reproducing” whenenough organisms have been inactivated that they are unable to maintaina viable population and thus dwindle until the remaining organismscannot sustain an infection. The term “kill,” as used throughout, refersto the cessation of metabolic processes in the organism. This targetedinactivation and killing of undesirable cells can be used to treatdisorders such as cancer, tumors, and autoimmune disorders such aspsoriasis. See for example U.S. Provisional Application 60/844,642 filedSep. 15, 2006, which is incorporated herein by reference, to WilliamCumbie, which discusses treatment of cancer using UV light, includingamong other things, treatment of skin cancer. This type of treatment hasnot been used earlier by those skilled in the art because it was feltthat germicidal light could not penetrate deeply enough to be effectiveand because the most potent germicidal light (UV) can be carcinogenic.However, advances in unrelated fields combined with new researchresulting from the inventor has shown that the penetration of germicidallight can be enhanced and even without enhancement the small amount iflight that penetrates is sufficient to be efficacious to a high degree.The potential carcinogenicity of UV light has deterred those skilled inthe art from pursuing it as a treatment for cancer itself. Cancer,however, is more likely from repeated exposures than from a few targetedtreatments using UV light. Thus, although there were several reasons whythose skilled in the art did not pursue this type of treatment, thisnovel way of thinking about treatment permits the invention to be usedefficaciously to treat these infections and disorders of the skin andnails. Additionally, this invention can be used to inactivate and killorganisms that cause infections, to disinfect wounds, or to cure warts,acne, etc.

Therefore it can be an object of the invention to treat an infection orprevent infection by treating a patient using germicidal light. Thistreatment can be used instead of surgery, radiation, or chemotherapy. Byavoiding the use of these more invasive procedure, significant sideeffects can be avoided.

It can be another object of the invention to treat an infection orprevent infection by treating a patient, by applying germicidal lightthat can be applied more quickly and precisely as compared to surgery,radiation, or chemotherapy.

It can be a further object of the invention to treat an infection orprevent infection by treating a patient with germicidal light that canbe used in conjunction with other therapies such as surgery, radiation,and chemotherapy to increase their efficacy.

It can be yet another object of the invention to treat an infection orprevent infection by treating a patient using germicidal light that canbe conditioned to permit it to better penetrate solid media, improvingthe efficacy of treatment. In some embodiments, light can be conditionedby using multichromatic light. In some embodiments, light can beconditioned by using a strobe light.

It is also can be an object of the invention to treat an infection orprevent infection by treating a patient by applying germicidal lightthat can be conditioned to make it more lethal to organisms and cellswhich improves the efficacy of treatment, including using wide spectrumlight.

Additionally, it is an object of the invention to apply germicidal lightto inactivate and kill organisms that cause infections, wounds, warts,acne, etc.

These objects of the present invention are not exhaustive and are not tobe construed as limiting the scope of the claimed invention. No oneembodiment need encompass all of the objects or any of the objects.

3 DRAWINGS

Attached are the following drawings:

FIG. 1 is a diagrammatic view of a light according to an embodiment ofthe present invention for use in treating skin or nail.

FIG. 2 is a diagrammatic view of a light according to an embodiment ofthe present invention for use in treating an internal orifice.

FIG. 3 is a diagrammatic view showing various bands of light.

FIG. 4 is a diagrammatic view of a light device according to a preferredembodiment of the present invention for use in treating skin or nail.

FIG. 5 is a diagrammatic view of a light device accessories according toa preferred embodiment of the present invention for use in treating skinor nail.

These drawings are illustrative or representative treatments and are notintended to be exhaustive. Those skilled in the art will readily discernadditional applications that are covered by this technology and aretherefore included in this disclosure such as treatment of warts,superficial skin infections, etc.

4 DETAILED DESCRIPTION

To achieve the objects of the invention, the invention takes advantageof the previously unrecognized fact that although it is true that UVCdoes not penetrate tissue easily, a small amount can penetrate for ashort distance into relatively solid material such as tissue and nails.The small amount of UVC light that does penetrate does so well enough toinactivate or kill cells that are undesirable. This is an unexpectedresult and forms one of the foundations for the novel use of germicidallight to treat skin and nail infections. See Cumbie, U.S. Pat. No.6,960,201 which is incorporated herein by reference.

Ultraviolet (UV) light can also be carcinogenic. It is thereforeunobvious and unexpected that UV light may be used successfully to treatcancerous cells. This has prevented UV light from being researched as acure for cancer—particularly skin cancer, which appears to be caused byexposure to sunlight—particularly UV light. However, it is the chronicexposure to ultraviolet light that is the greatest cause of itscarcinogenicity. Acute exposure is not as carcinogenic as chronicexposure because it does not expose cells to UV light repeatedly therebycausing mutations that eventually evolve into cancerous cells.

The invention disclosed in this application can also be used toinactivate or kill cells that have become detrimental to health, such ascancer cells and tumors. Furthermore, this invention can be used toinactivate organisms that can cause disease, infections, wounds, andother disorders.

4.1 UVC Light Dose Necessary to Inactivate Microbes

UVC light has the ability to inactivate organisms by damaging theorganism's genetic material, which in turn prevents it from reproducing.Inactivation energies for organisms using UVC light alone vary from lessthan 1 mj/cm2 to greater than 100,000 mj/cm². This is a very wide range,however, most organisms tend to be inactivated in the lower 1% of thisrange, i.e., 1 mj/cm² to 1,000 mj/cm² (1 j/cm²).

The EPA guidance manual on Alternate Disinfectants and Oxidants (April1999) devotes Chapter 8 to a discussion of germicidal UV as adisinfectant for drinking water. The manual notes that a UV wavelengthof 240 to 280 nm is highly absorbed by the RNA and DNA of amicroorganism. The absorbance of UV by the organisms results in thedamage to the organism's ability to reproduce. The damage is oftencaused by the dimerization of pyrimidine molecules. A dimer is amolecule consisting of two identical simpler molecules and dimerizationis the process of linking the two molecules together. Dimerization ofthe pyrimidine molecules distorts the DNA helical structure. The EPAguidance manual also notes that the dose to inactivate 90% of most typesof organisms is very low with a typical range of 2 to 6 mJ/cm². Themanual notes that the germicidal radiation can be generated by a numberof sources including a low pressure mercury lamp emitting at 254 nm, amedium pressure lamp emitting at 180 to 1370 nm, or lamps that emit atother wavelengths in a high intensity pulsed manner.

4.2 Wide Spectrum Germicidal Light

Wide spectrum light has germicidal properties and can offer someadvantages over the use of narrowband UV light. These advantages caninclude the following:

-   -   a. Although the UV component of polychromatic light still does        not penetrate easily, other wavelengths can penetrate better and        thus contribute relatively more than usual to inactivating        organisms. Thus, polychromatic radiation has the potential to        inactivate organisms using less energy in the UVC range than        would be required using UVC light alone.    -   b. Polychromatic light or light containing multiple wavelengths        can act on various processes of the cells and cause inactivation        of organisms at lower energies than ultraviolet light alone. In        addition to greater inactivation of organisms using        polychromatic light, the inactivation of a wider variety of        organisms is possible since the multiple bands of light affect        each type of organism differently and will thus affect a wider        variety of organisms.    -   c. Because different wavelengths are absorbed by different part        of each organism, the use of multiple wavelengths increases the        chance that structures that are essential to the organism will        be inactivated thus rendering the organism harmless.

Wideband UVC light, defined as light that covers the entire UVC spectrumof 240 nm to 280 nm (as opposed to monochromatic UVC light that emitsprimarily at one wavelength, such as 254 nm for a low pressure mercurylamp) has germicidal properties and offers advantages to the use ofnarrowband UV light. These advantages include the following:

-   -   a. Since all of the UVC range exhibits strong germicidal        properties, it is possible to spread the dosage over the entire        band, limiting the amount of light that is delivered at any one        wavelength. This can help alleviate any negative responses to        the UV (such as erythema).    -   b. While the optimal range of UVC for inactivation of organisms        due to the formation of pyrimidine dimers is at centered about        258 nm, research indicates that various organisms are more        affected at other ranges of the UVC spectrum. Use of broad band        UVC across the range of 240 nm and 280 nm ensures that energy is        delivered at wavelengths to which all organisms are susceptible.

Pulsed light variants of polychromatic and UVC light also havegermicidal properties and can offer advantages over the use ofnarrowband UV light. These advantages can include the following:

-   -   a. Applicant's laboratory data shows that high intensity pulses        are significantly more effective at penetrating tissue than when        the same amount of continuous monochromatic light is applied        over a longer period of time. Other research that Applicant has        performed indicates that pulsing of high-energy, wide spectrum        light can increase the depth of penetration through tissue by        several orders of magnitude compared to continuous monochromatic        light. This finding, which is not common knowledge to those        skilled in the art of treating skin and other body disorders,        permits the novel use of pulsed light to inactivate organisms at        a much lower dose of UVC than continuously emitting light.    -   b. Since pulsed light can be more effectively used to penetrate        tissue and inactivate organisms, it can substantially reduce the        time necessary for treatment.    -   c. Additionally, since the pulsed light can be used to more        effectively to penetrate tissue, it can be used to treat        infections that are substantially deeper than surface        infections.    -   d. Pulsed light emits significantly higher energy in a very        short time period compared with continuous light. These short,        high intensity pulses appear to overwhelm cells and damage vital        components that are unable to dissipate the excess instantaneous        energy being applied. Additionally, short pulses of light with        comparatively longer periods of low light or no light permit        time for energy to dissipate and thus limits the amount of heat        experienced by surrounding tissues, thereby limiting collateral        damage    -   e. The very high peak of the energy pulse is often several        orders of magnitude greater than the average energy applied.        This high peak dose is more likely to exceed the threshold        energy (also called the energy of activation), thereby driving        reactions that would not begin until this threshold is reached.        Thus, these peak doses can trigger reactions that will        contribute to the inactivation of organisms by damaging vital        components or forming compounds that are antibiotic in nature        such as singlet oxygen or ozone.    -   f. Pulsed light can damage undesirable cells with a lower        overall doses since the pulsed light can deliver extremely high        doses that overwhelm the cell in short pulses, yet with        substantial time periods (“down time”) between pulses. Thus an        organism may be exposed to a peak of several orders of magnitude        greater than if the light were uniformly spread over time.

Coherent light variants of polychromatic and UVC light such as lasersalso have germicidal properties and can offer advantages to the use ofnarrowband UV light. These advantages can include the following:

-   -   a. Lasers can be pulsed to offer the same advantages that other        pulsed light sources possess, namely they can penetrate better        than continuous light.    -   b. All lasers make use of coherent light of a very narrow band.        The lasers can thus be tuned to do the most damage to infectious        organisms while not affecting other organisms as greatly. For        example, if a particular organism is best deactivated at a        wavelength of 245 nm, a tunable laser could be used to deliver        light precisely at the 245 nm wavelength. Surrounding tissue and        organisms would not be as greatly affected since most typical        organisms are affected most strongly between 258 nm and 262 nm.

4.3 Pulsed Polychromatic Light Dose Necessary to Inactivate Microbes

While most wavelengths are not germicidal by themselves, they can havesynergistic effects that aid in inactivating organisms. When combinedwith the germicidal effects of UVC light, multichromatic sources canoften lower by up to an order of magnitude or more the required dose ofthe potentially harmful UVC. Xenon flash lamps can be a particularlyattractive source of multichromatic light because in addition toproviding multiple wavelengths of light, the xenon flash lamps can bepulsed to provide extremely high momentary doses of light allowing thelight to be safely delivered repeatedly via a strobe mode.Multichromatic light can have the following advantages, especially whena characteristic of the emitted light has been altered to enhance theproperties of the light. A “light characteristic” is a property oflight. Light characteristics include but are not limited to, wavelength,energy, penetration, frequency of exposure (pulsing), length ofexposure, etc.

-   -   a. a. High peak doses—very high peak doses can be delivered        using high energy pulses that have short durations. The overall        energy applied can still be lower on average than applied by a        continuous lamp, however, the peak doses could be 10 to        1,000,000 times or more the average dose. The high peak doses        can act as a ‘punch’ to cause damage that might not be        accomplished at lower energies. An analogy would be applying        pressure to drive a nail through a piece of wood. If a person        pushed on a nail with his hand for days he may not be able to        drive a nail through wood. However, a strong momentary blow to        the nail delivered via a hammer can drive the nail quickly. The        total amount of energy applied by hand to the nail could        actually be greater but the momentary energy application via a        hammer is more likely to successfully drive the nail. In the        same way high peak doses have the ability to damage the genetic        material quickly and effectively without the use of high average        doses. Recent laboratory data indicate that a dosage applied as        a high-energy, pulsed strobing of light can increase its ability        to penetrate tissue by several orders of magnitude.    -   b. Repetitive pulsating doses—a lamp that is pulsed, or strobed,        can deliver over one hundred intense pulses per second or more.        These pulses have the effect of rapidly changing the environment        of the organism and also affecting its biological processes. The        repetitive fluctuations can do damage that continuous light        might not accomplish, while at the same time protecting the        surrounding skin from deleterious effects that other forms of        light at the same dosage might cause. An analogy would be the        flexing of a piece of metal. While it might flex once or for a        dozen times without breaking, continuous flexing of a piece of        metal will cause it to fatigue and eventually break. With pulsed        light, the strobing of light at multiple pulses per second can        affect this type of fatigue and failure in an organism in a        short period of time. The strobing may also create harmonic        waves, which can do additional damage to the cellular processes        of the organism.    -   c. High Voltage Pulsing—Pulsing with very high voltage can shift        the spectra of the light to shorter wavelengths and dramatically        increase the amount of light emitted in the UV range, which is        also the wavelength that has been found to be the most        germicidal. High voltage pulsing can deliver an extremely high        peak dose (generally peaks measured in megawatts) in a very        small time period (generally time periods of microseconds). For        example, the RC-700 that was used in pilot clinical trials        discussed in this application delivered a 0.2 megawatt (200,000        watts) peak power dose when the average power was only 600 watts        which makes the peak dose approximately 333 times the average        dose (note this data is input power, not light energy output).        Additionally, this pulse was delivered via pulses that had a        width of 25 microseconds with 120 pulses delivered per second.        Thus, the total ‘on’ time of the lamp was 3 milliseconds per        second, or to put it another way the lamp was ‘on’ only 0.3% of        the time. This equates to a peak instantaneous dose of more than        one hundred thousand times the average dose if the same light        had been applied at a constant rate with no pulsing.

4.4 Preferred Methods and Apparatus of the Invention

Referring to the drawings, a method and means for the prevention andtreatment of undesirable cells and organisms is shown. The method, asseen in FIG. 1, includes irradiating a target tissue 104, such as a skinor nail, with light 106. The procedure uses specific types and levels oflight having a germicidal electromagnetic radiation component to takeadvantage of the previously unrecognized ability of radiation topenetrate tissues and other matter sufficiently to inactivate organismsand undesirable cells without unduly harming the host (e.g., human oranimal patient). It should be noted that in addition to killing a cellor organism, said method and means can also keep activation dose at asafe (“lower”) level by inactivating an organism.

This method and means also combines the previously unrecognized abilityof pulsing of light to significantly enhance the light's ability topenetrate tissue and to increase the efficacy of said germicidal light.The method also makes use of the enhanced efficacy of pulsed light toinactivate cells by disruption of essential cellular processes due tothe light's ‘strobing’ effect and its high energy peak pulses. Themethod and means to inactivate cells and organisms also includes thenovel combination of using polychromatic light combined with filtersthat prevent undesirable bandwidths from reaching the area to betreated.

The following descriptions of the invention are not intended to limitthe scope of the invention but are made merely for the purpose ofdescribing general principles of the invention. Further, it must beunderstood that no one embodiment of the present invention need includeall of the aforementioned objects of the present invention or thefeatures of the preferred embodiment of the invention. Rather, a givenembodiment may include one or none of the objects or features.Accordingly, the preferred embodiments and objects of the invention arenot to be used to limit the scope of the claims of the presentinvention.

4.5 Description of Device to Prevent and Treat Infections

As shown in FIG. 1, a device 100 to prevent and treat infections canincorporate a number of special features to enhance treatment andpromote safety. For example the treatment device may contain a lightsource 110 that can be tuned to a specific spectral output or has afixed spectral output 106.

This can be accomplished by the use of a tunable laser, multiple lamps,or by the use of one or more filters to screen out wavelengths that arenot desirable. A combination of lamps and sources 110,112 may also beused. The treatment device may also contain very small lamps 114 (FIG.2) capable of being inserted in small spaces 116 or directly on thesurface to be treated. This will permit its use to treat orifices orinternal passageways 116 that may be affected such as the pulmonarytract or the digestive tract. Light can also be concentrated andtransmitted via a light guide 118 thus permitting high doses to beprecisely applied to the area to be treated. Several attachments may beadded to the device to permit light to be directed to the area to betreated including attachments 120 that evenly diffuse light to a largerarea being treated or to direct and concentrate light to a smaller areabeing treated. Attachments 118 can also be used that are flexible andconform to the area being treated and are capable of transmitting lightto the area being treated.

The treatment device can use polychromatic light to prevent and treatinfections. This light may be conditioned in a number of ways to make itmore efficacious and safer. For example, the light can be pulsed toachieve an improvement in efficacy of three orders of magnitude or more.Also, the unwanted bandwidths of the light can be filtered out toimprove the safety of the device.

The treatment device can also use monochromatic light or narrowbandlight to treat cells or organisms. This light can be provided by apolychromatic light source that is filtered to provide only a limitedbandwidth, a tunable laser, or a monochromatic light source such as someexcimer lamps emit or that a low pressure mercury lamp would emit.

It should be noted that the device can be used to treat animals as wellas humans. In fact, the ability of pulsed light to enhance penetrationgreatly increases the devices efficacy for animals that have thickerhides or nails (e.g., hoofs or claws).

4.6 Mechanisms of Inactivation

It has been noted in co-pending U.S. application Ser. No. 11/185,791,filed Jul. 21, 2005, that there is a distinct difference in destroyingan organism or cell by heating the entire organism and by destroying itby damaging its genetic material. “Thermocide,” as used in thisapplication, is defined as a method of inactivating or killing anorganism, where the main cause of destruction is by heating the entireorganism. “Geneticide,” as used in this application, is defined asdestroying an organism by damaging its genetic material, which kills orinactivates the organism. Geneticide may require a much lower level ofelectromagnetic radiation to achieve. Thus, the treatment and devicedescribed in this application does not rely on thermocide to inactivatean organism or cell. Instead the primary mode of inactivation of a cellor organism is by geneticide.

It should be noted that although damage to the genetic material of acell is the major cause of geneticide, other processes can contribute tothis process, which are not directly genetic such as destruction of mRNAand the rupture of cell membranes. Thus, DNA or RNA is “directlyaltered” when the treatment damages the genetic material containing allthe genes of the organism.

In addition to geneticide as defined herein, and explained in the Ser.No. 11/185,791 application, it is possible to also kills cells ororganisms solely by destroying structures vital to the existence of acell or organism. Examples include destruction of membranes, ribosomes,mitocondria, and other structures that the cell or organism require.Additionally, it is possible to damage but not destroy a number of saidstructures where the damage to any one structure would not normallyresult in the inactivation of the cell or organism but the combinationof damage is sufficient to inactivate the organism. In all of thesecases, heating the entire organism does not facilitate inactivation.Rather, cumulative damage or destruction of specific components of thecell or organism leads to death or inactivation. While this may beaccompanied by instantaneous heating of these components the entireorganism is not uniformly heated to destroy it outright by excessiveheat. It should be noted that while the temperature of the tissuesurrounding the treated area may rise, this temperature rise is lessthan what is sufficient to destroy the cells or organisms by excessiveheat alone. This damage or destruction of vital components of the cellor organism is included in the definition of the term “cell death.”

4.7 Enhanced Penetration of Germicidal Radiation Through Tissues by Useof Pulsed Polychromatic Light

As noted above there has been virtually no published research onoptimizing the transmission of UVC through tissues. Optimizing thepenetrating power of UVC opens up a much wider set of options for usingUVC to prevent and treat infections both internally and externally forhumans and animals.

One way to substantially increase the penetrating power of UVC and otherforms of germicidal radiation is to administer the light in the form ofvery short, high intensity pulses. This form of application takesadvantage of the ability of a powerful peak dose to punch throughintervening tissue. It also creates a pulsed environment whereparameters change rapidly, which is also detrimental to an organismtrying to maintain a steady state biotic condition. The high intensityalso ensures that the minimum dosage strength necessary to damage anorganism is delivered while the ‘off times’ in between the pulsesgreatly decreases the amount of energy that actually is delivered thusminimizing exposure.

EXAMPLE 1

To illustrate the effect on the use of high intensity pulsing to enhancepenetration of tissues two devices were compared. One unit was a lowpressure mercury lamp unit manufactured by American Ultraviolet, modelCE-12-2H with two UV bulbs each consuming 6 watts of energy and emittingapproximately 85% of their light as UV at 254 nm. See Table 1 below.This unit represented a steady state, non-pulsing source of UVC. Thesecond device was a xenon pulsed lamp manufactured by Xenon corporation,model RC-700 capable of pulsing 120 times per second (25 μs on and 8.3ms off). The RC-700 unit was capable of providing an average output of 1to 5 mw/cm² of UVC at 254 nm when its intensity was averaged over aperiod of several seconds. While the unit emitted a low average wattageof UVC, when it was pulsing (its pulse time was 0.3% of the total time)it could emit an equivalent peak dose of between 333 to 1666 watts ofUVC during the each short burst, or an equivalent of about 13 to 66 μJof UVC at 254 nm per pulse. Note that this data is applied light energy,not input power.

Detection of UVC was accomplished using an IL1700 radiometer equippedwith an SHD240 detector. This device can be used to measure peak dosagesor can provide an average dosage over time. The average dosage over timewas of interest in this research since the timing and the length ofindividual pulses of the xenon flash bulb were well documented.

The tissue used were nail clippings taken from a person who did not havenail infections. Nail clippings were used since the research was to beapplied first to treatment of nail infections. However, similar resultsare expected from exposing skin and other tissues to these forms ofgermicidal light.

Five nail clippings were tested. Two plates with a ⅛-in holes were usedto test the nail clippings. A reading was taken when no plates werebetween the lamp and the detector, another reading when the plates werein place but no nail was covering the ⅛ in hole, and one reading withthe nail sandwiched between the plates to cover the ⅛-in hole. Theindividual data for each nail clipping are as follows:

TABLE 1 Transmissivity testing comparing Low Pressure Mercury Lamp(continuous light) and Xenon Pulsed Flash Lamp Low Pressure MercuryXenon Pulsed Lamp Flash Lamp Meter reading Meter reading Notes NailClipping 1 A. No Plate ‘Hi’ 5.0 × 10E−5 B. Plate with no nail 2.0 ×10E−4 2.3 × 10E−5 C. Plate with nail 1.5 × 10E−9 1.6 × 10E−7 D.Transmissivity (C/B) 7.5 × 10E−6 6.9 × 10E−13 Pulse lamp approximately1000 times more effective Nail Clipping 2 A. No Plate ‘Hi’ 4.9 × 10E−5B. Plate with no nail 1.8 × 10E−4 3.3 × 10E−6 C. Plate with nail 5.6 ×10E−10 1.5 × 10E−8 D. Transmissivity (C/B) 3.1 × 10E−6 4.5 × 10E−3 Pulselamp approximately 1400 times more effective Nail Clipping 3 A. No Plate‘Hi’ 4.8 × 10E−5 B. Plate with no nail 1.3 × 10E−4 1.6 × 10E−5 C. Platewith nail 1.0 × 10E−9 1.7 × 10E−7 D. Transmissivity (C/B) 7.7 × 10E−61.1 × 10E−2 Pulse lamp approximately 1400 times more effective NailClipping 4 A. No Plate ‘Hi’ 4.9 × 10E−5 B. Plate with no nail 9.9 ×10E−5 2.0 × 10E−5 C. Plate with nail 1.0 × 10E−9 6.7 × 10E−8 D.Transmissivity (C/B) 1.0 × 10E−5 3.4 × 10E−3 Pulse lamp approximately350 times more effective Nail Clipping 5 A. No Plate ‘Hi’ 4.9 × 10E−5 B.Plate with no nail 2.2 × 10E−4 2.0 × 10E−5 C. Plate with nail 9.0 ×10E−10 8.2 × 10E−8 D. Transmissivity (C/B) 4.1 × 10E−6 4.3 × 10E−3 Pulselamp approximately 1000 times more effective

The data from testing of nail clippings indicates that a pulsed sourceof UVC is capable of penetrating a nail between 350 and 1400 times moreeffectively. On average the pulsed light was 1000 times as effective(three orders of magnitude) and capable of penetrating a nail as a lowpressure mercury lamp of equivalent UVC output. Thus a dosage of lightthat would take one hour (3,600 seconds) to deliver underneath a nailusing the American UV model CE-12-2H lamp could be delivered using aXenon RC-700 lamp in approximately 15 seconds even though the averageUVC output at 254 nm from the RC-700 is only 25% that of the AmericanUltraviolet lamp.

4.8 EXAMPLE 2 Clinical Trials Using Germicidal Light to Treat NailInfections

Clinical trials were conducted consisting of two prototype devices eachof which was used to treat 15 subjects each (30 total). One device,labeled Prototype A, was a low pressure mercury lamp (LPML) that wascapable of providing at total of 17 mw/cm² of UVC at 254 nm over thearea to be treated. The second device labeled Prototype B, was a pulsexenon lamp (XPL) capable of providing pulsed full spectrum light fromapproximately 180 nm to more than 1600 nm. Prototype B was capable ofproviding a total of 3.87 mw/cm² of UVC from 240 to 280 nm over the areato be treated.

Fifteen subjects received treatment using Prototype A. Each treatmentirradiated the target nail with 0.18 mw/cm² of UVC at 254 nm for 45minutes for 4 sessions each spaced one week apart. Total dosage of UVCto the top of the nail was therefore approximately 22 J/cm² during eachof the four treatments. UVC light was generated by a commerciallyavailable low pressure mercury lamp manufactured by Heraeus (modelNG6062) which is used to disinfect surfaces such as food containers.

Fifteen subjects received treatment using Prototype B. Each treatmentirradiated the target nail with 3.87 mw/cm² of UVC from 240 to 280 nmfor 8 minutes for 4 sessions each spaced one week apart. Total dosage ofUVC to the nail was therefore approximately 1.86 J/cm² for each of thefour treatments or about 1/12^(th) as much given using Prototype A.Light for the treatment was generated by a commercially available xenonpulsed lamp manufactured by Xenon (model RC-700) which is used todisinfect surfaces such as food containers. As opposed to the narrowbandmercury lamp, the xenon lamp provide multiple wavelengths of light. Inaddition to the UVC wavelengths of interest, the lamp also provided thefollowing dosages of light during each treatment lasting 8 minutes:

-   -   Far UV from 180 nm to 240 nm—0.8 J/cm²    -   UVC from 240 nm to 280 nm—1.9 J/cm²    -   UVB from 280 nm to 320 nm—3.8 J/cm²    -   UVA from 320 nm to 400 nm—15 J/cm²    -   Visible light from 400 nm to 750 nm—113 J/cm²    -   Infrared from 750 nm to 880 nm—1.1 J/cm²    -   Infrared above 880 nm—estimated to be about 67.5 J/cm²

Note that total dosage of light in the UV range was 22 J/cm² and totallight dosage (between 180 and 880 nm) was 135 J/cm2 for each of thetreatments with the xenon pulsed light. See the light spectrum referencetable provided in FIG. 3.

Results of Clinical Trials—Of the 15 subjects treated with Prototype A,three dropped out of the study and 12 were evaluated after 1, 2, 3, 8,and 12 weeks. Average clear new nail growth was 2.5 mm after 12 weekswith 7 of the 12 subjects having more than 2 mm of new nail growth.Subjects were also graded on the IGA (Investigator Global Assessment)scale of 0 to 5 for nail appearance with lower numbers representingclearer nails and higher numbers less translucent nails. On average,during the trials there was a 0.27 improvement on this scale (changingfrom 2.64 to 2.37) for patients treated with the Prototype A light.

The dosages applied by the low pressure mercury lamp and the xenonpulsed lamp were as follows:

-   -   LPML—dose to top of nail=22 J/cm², dose to skin under nail =1.4        mJ/cm², average dose to nail=11 J/cm².    -   XPL—dose to top of nail=1.9 J/cm², dose to skin under nail=11        mJ/cm², average dose to nail=1.0 J/cm².

It should be noted that while only 1/11^(th) as much UVC was appliedusing the XPL approximately 8 times more UVC penetrated the nail to theskin the was under the nail. The average dosage of UVC applied to thecross-section of the nail was also 11 times higher using the LPML. Forthe clinical trials it was felt that the much higher overall dose wouldoffset it's the LPML lower penetrating ability and that both sets ofsubject would have similar results.

Of the 15 subjects treated with Prototype B, two dropped out of thestudy and 13 were evaluated after 1, 2, 3, 8, and 12 weeks. Averageclear new nail growth was 2.5 mm after 12 weeks with 8 of the 13subjects having more than 2 mm of new nail growth. Subjects were alsograded on the IGA (Investigator Global Assessment) scale of 0 to 5 fornail appearance. On average there was a 0.69 improvement on this scale(changing from 2.64 to 2.35).

The data indicate that both devices were capable of efficaciouslytreating the infection to so that new nail growth would be clear.Additionally, however, it was noted that the broad spectrum xenon pulsedlight was also capable of providing improvement in the appearance of thenail.

It appears, therefore, that UVC applied to nails with a low pressuremercury lamp is able to inactivate organisms that cause nail infectionsand clear the infection. It also appears that pulsed, broad spectrumgermicidal light is even more efficacious in curing nail infections.This occurred even though the UVC dose of the pulsed light was less than10% of that delivered by the low pressure mercury lamp. Thus, whiletreatment with UVC alone successfully treated nail infections, treatmentwith broad spectrum light pulsed germicidal light had the unexpectedresult of being more efficacious at much lower doses.

It should be noted that although the clinical trials focused on nailinfections, the results can be applied to the treatment of skin andother tissues of the body. Enhancement of the delivery of germicidallight (by pulsing, using wide spectrum light, and/or by othermodifications) can significantly improve the efficacy of treatment andresult in a lower overall dose required.

4.9 Discussion of Research Results Using Pulsed Lamp Technology

As demonstrated in Example 2, results from lab research on the use ofshort, high intensity pulses indicate that pulsing can increasetransmissivity through the nails by approximately 3 orders of magnitude(1000 times). The increase in transmissivity does not take into accountthe added synergistic germicidal effects that may be obtained from usinga wide band polychromatic light source. Thus, it is possible to enhancethe delivery of germicidal light by several orders of magnitude to makeit more effective to prevent and treat infections.

Clinical trials conducted on nail infections verify that wide bandpulsed germicidal light can be used to enhance the treatment ofundesirable tissue and cells and can do so at a much lower dose than acomparable dose of UVC delivered by a narrowband continuous lightsource.

One of the implications of this research is that lamps of much lowerpower could be pulsed to greatly enhance their efficacy. One possiblesource of light that becomes much more attractive because of thisdiscovery is the use of UV emitting LEDs. In the last several years LEDshave been developed that can emit light in the UVC range. These LEDshave begun to be used in germicidal applications such as thedisinfection of air and water. However, they would not be as attractiveto prevent and treat infections due to their low power, which has beenthought to greatly decrease their ability to penetrate and deliver therequired dose. If LEDs emitting UVC were pulsed correctly, such asthrough the use of selective filters, shields, mirrors, regulators ormodulators, the LED lights have great potential to treat infections.

In addition, there are a wide variety of excimer lamps that emit lightin the UVC range that can be pulsed to increase their efficacy. Forexample xenon-iodine (XeI, also designated as XeJ) excimer lamps emitsmost of its light at 253 nm. Additionally chlorine (Cl—Cl) excimer lampsemit at 258 nm and xenon-bromine (XeBr) emit at 283 nm. While the latteremission is just outside the UVC range it still has the potential to bevery germicidal. Pulsing of these lamps could greatly increase theirefficacy in treating infections. The ability of these lamps to deliverone or several high energy pulses that are precisely targeted also makesthem ideal for use as a preventative application. For example, thoseprone to nail infections may have a preventative dose applied duringperiodic visits to a podiatrist.

Additionally, it is possible to modify the current of a pulsedpolychromatic light source such as a Xenon pulsed lamp by applying ahigher current to it to force more of its light to be emitted in the UVCrange. Table 2 below illustrates the difference between low current andhigh current operation.

TABLE 2 Xenon Flash Lamp Approximate energy distribution for Hi and Locurrent operation High Current Operation Low Current Operation Wave-Wave- length Intensity Percent length Intensity Percent 200 0.25 3.25%200 0.18 2.14% 250 0.75 9.74% 250 0.27 3.21% 300 0.55 7.14% 300 0.354.16% 350 0.5 6.49% 350 0.45 5.35% 400 0.65 8.44% 400 0.45 5.35% 450 0.79.09% 450 0.53 6.30% 500 0.7 9.09% 500 0.58 6.90% 550 0.65 8.44% 550 0.55.95% 600 0.42 5.45% 600 0.5 5.95% 650 0.33 4.29% 650 0.45 5.35% 7000.32 4.16% 700 0.4 4.76% 750 0.28 3.64% 750 0.4 4.76% 800 0.32 4.16% 8000.35 4.16% 850 0.35 4.55% 850 0.6 7.13% 900 0.3 3.90% 900 0.7 8.32% 9500.25 3.25% 950 0.6 7.13% 1000 0.2 2.60% 1000 0.6 7.13% 1050 0.1 1.30%1050 0.3 3.57% 1100 0.08 1.04% 1100 0.2 2.38% Total 7.7 100.00% Total8.41 100.00% Comparison of Low and High Current Operation High currentoperation has three times the UVC output of low current operation perapplied Joule High current operation has about two times the UVB outputof low current operation per applied Joule

4.10 Undesirable Wavelengths of Polychromatic Light and Methods toMitigate Problems

“Polychromatic light” refers to a wide range of light. In someembodiments, polychromatic light can be provided by a xenon flash lamp.Some wavelengths in polychromatic light are undesirable due to theirside affects. For example UVB in even low doses can cause sunburn andhas also been shown to be carcinogenic. This is one of the reasons thatpolychromatic light has not been used on humans or animals. However, itis possible to use filters to reduce or totally eliminate undesirablewavelengths of light. This can be accomplished by a variety of meanssuch, for example, as the use of notch filters (that exclude only a veryspecific band of light), mirrors that preferentially reflect certainwavelengths of light but absorb unwanted bandwidths, or thin filmsapplied over optically transparent materials to filter out undesirablebandwidths. This is not an exhaustive list but is illustrative of typesof filtering that one skilled in the art could use to screen outundesirable light. The present invention is not limited to a specifictype of filter. The type of filter described above has not been used inthe past since the filtering technology has only been used in a varietyfields that are not health related and those skilled in the art oftreating infections have not thought apply it in this field.Additionally, filters of this type can be prohibitively expensive.However, this novel combination of technologies greatly enhances the useof polychromatic light applied to tissues to inactivate undesirablecells or organisms. From table 1 above it appears that averagetransmission of UVC through the nail using a low pressure mercury lampis approximately 6.5E−06 while the average transmission using a xenonpulse lamp is 6.0E−03 which indicates that the pulsed light has about1000 times the ability to penetrate nails

4.11 Use of Synergistic and Other Germicidal Wavelengths to EnhanceTreatment

Other wavelengths can also act germicidally besides the UVC band and arediscussed in detail in U.S. application Ser. No. 11/154,707, filed Jun.17, 2005 which is incorporated by reference into this application. Anexample of these wavelengths is illustrated by recent experiment dataconducted in March and April of 2007 which included a semi-quantitativeevaluation of whether there are other germicidal wavelengths generatedby a low pressure mercury amalgam lamp. Bakers Yeast was used as theindicator organism since it is easy to culture. One-quarter teaspoon ofbakers yeast was mixed in one-quarter cup of warm water and fullydissolved. One ml of solution was put in each of 6 small sterilecontainers. Each container was irradiated as follows:

-   -   1A—fully covered, no UV light    -   2A—Irradiated with UV light for 5 minutes, no filter used    -   3A—Irradiated with UV light for 5 minutes, a 275 nm bandpass        filter was used (only light above 275 nm reached the yeast)    -   4A—Irradiated with UV light for 5 minutes, a 325 nm bandpass        filter was used (only light above 325 nm reached the yeast)    -   5A—Irradiated with UV light for 5 minutes, a 425 nm bandpass        filter was used (only light above 425 nm reached the yeast)    -   6A—fully covered, no UV light. However, the water used to dilute        the yeast was combined with approximately 10 grams of nail        clippings that had been irradiated by UV light for 5 minutes.        This was done to determine if the UV light possibly changed the        nail so that it had a substance toxic to the yeast which would        then retard its growth.

Once these samples were exposed, six more samples identical to abovewere prepared and irradiated. These were labeled 1B, 2B, 3B, 4B, 5B, and6B respectively.

The yeast was then transferred to individual Millipore Yeast culturetubes and incubated for 72 hours. There was no growth observed after 72hours so the tubes were left for an additional week in ambientconditions. The following results were observed after 10 days total time(72 hours plus 7 days):

1A and 1B—6 and 2 colonies—ave. 4 colonies

-   -   2A and 2B—1 and 1 colonies—ave. 1 colonies    -   3A and 3B—3 and 1 colonies—ave. 2 colonies    -   4A and 4B—2 and 2 colonies—ave. 2 colonies    -   5A and 5B—5 and 5 colonies—ave. 5 colonies    -   6A and 6B—5 and 3 colonies—ave. 4 colonies

The colonies were small white and fluffy to the naked eye. The wereabout 1 grid in diameter for the most part.

The data indicates several findings. One is that using water thatirradiated nails have been soaked does not effect growth. Second is thatUV at 254 nm is effective in inactivating yeast. Third is thatwavelengths generated by a mercury lamp above 425 nm has littlegermicidal effect. Finally, since the sample irradiated with a 275 nmand a 325 nm bandpass filter have similar inactivation (about half thatof the sample with no filters). This indicates that the germicidal lightis in the range of 325 nm to 425 nm (since if it was between 275 to 325nm there would be a difference in the two samples growth). In the rangeof 325 nm to 425 nm there are only two wavelength generated by the lowpressure mercury lamp that have any magnitude—they are at 365 nm (1.7%of the amount of 254 nm light generated) and 405 nm (2.0% of the amountof 254 nm light generated). Therefore, it appears that one or both ofthese wavelengths have germicidal characteristics with respect to yeastand most probably other organisms. Additionally, since these wavelengthsare longer than UVC wavelengths they can penetrate better and thereforeare a useful adjunct to UVC therapy. Therefore, these two discretewavelengths are among those also claimed as germicidal and synergisticwavelengths that can be used to treat skin and nail infections, tumors,wounds, psoriasis, etc.

4.12 Mechanisms of Destruction Using Pulsed Light

Although the Applicant does not wish to be bound by any theory ofoperation a description of how pulsed light is efficacious is providedherein for illustrative purposes. Since there are many ways pulsed lightcan be said to be efficacious this description should not be taken asexhaustive or definitive but only exemplary.

It UVC range is germicidal since it is the band that most readilydamages the genetic material of an organism and prevents it fromreproducing. Although UVC in low doses can inactivate an organismsubstantially by damaging its genetic material, application of UVC inhigher doses can also damage other cellular structures and even kill thecell or organism if enough light is applied. Additionally, even very lowdoses of UVC can damage an organism or cell enough that it goes intoapoptosis, a form of programmed cell death.

Pulsing light can enhance the proportion of UV in light relative to therest of the spectrum. For example, as noted in this application pulsingof a Xenon lamp can more than double the amount of UV light below 300 nmcompared with a continuous xenon or a weakly pulsed xenon lamp. Roughlyspeaking, the more voltage that is applied per pulse the more UV thereis in proportion to the rest of the spectrum. Thus, very high voltagepulsing of xenon is a preferred way to increase UV output of a lamp.

Additionally, pulsing light can prove more efficacious since it hindersa cell or organism from equilibrating to static conditions. Thecontinuous change of state will not only stress an organism it will alsofatigue the organism and slow its response time. Very short pulsing oflight can also penetrate so quickly that an organism or cell cannotmount proper defenses.

Pulsed light also creates a much higher point input of energy, which isfar more difficult for a cell or organism to disperse that a lower,steady input of light. By applying very short, intense pulses it ispossible to apply peak energies that are a million times or morestronger in their peak than the same amount of light applied on acontinuous basis. This intense energy can totally destroy criticalstructures in an organism or cell, which will prevent it frommaintaining viability.

The use of wide band pulsed light has the advantage of overwhelming thecell with multiple light waves that can cause damage to variousstructures for the organism or cell. For example, the UVC range candamage the genetic material of the cell while the UVB or UVA banddamages the membrane of the cell or organism. Other bands may beabsorbed by other structures such as mitochondria. Thus, while UVC maydo the primary damage to a cell, the other wavelengths actsynergistically to inactivate the cell by killing it or by damaging itsability to reproduce.

UVC is about the shortest wavelength of light. Use of wideband pulsedhas longer wavelength and will thus enhance the penetration of the lightthrough tissue. Additionally, research indicates that the penetration ofUV is also enhanced by the inclusion of other wavebands. Thus, theinclusion of wideband light not only acts synergistically to inactivateorganisms and cells, it also acts synergistically to help UV penetratebetter.

4.12.1 Wide Spectrum Germicidal Light

Wide spectrum light has germicidal properties and offers some advantagesto the use of narrowband UV light. These advantages include thefollowing:

-   -   a. Although the UV component of polychromatic light still does        not penetrate well, other wavelengths can penetrate better and        thus contribute relatively more than usual to inactivating        organisms. Thus, polychromatic radiation has the potential to        inactivate organisms using less UVC than the use of UVC light        alone    -   b. Multiple wavelengths of light can acts on various processes        of the cells and cause inactivation of organisms at lower        energies than ultraviolet light itself. In addition to greater        inactivation of organisms using polychromatic light, the        inactivation of a wider variety of organisms is possible since        the multiple bands of lights affect each type of organism        differently and will thus affect a wider variety of organisms.    -   c. Different wavelengths are absorbed by different part of each        organism thus use of multiple wavelengths increases the chance        that structures that are essential to the organism will be        inactivated thus rendering the organism harmless.

Wideband UVC light, defined at light that covers the entire UVC spectrumof 240 nm to 280 nm as opposed to monochromatic UVC light that emitsprimarily at one wavelength (such as 254 nm for a low pressure mercurylamp), also has germicidal properties and offers advantages to the useof narrowband UV light. These advantages include the following:

-   -   a. Since all of the UVC range exhibits strong germicidal        properties it is possible to spread the dosage over the entire        band, which thus limits the amount that is delivered at any one        bandwidth. This may act to alleviate any negative responses to        the UV (such as erythema).    -   b. While the optimal range of UVC for inactivation of organisms        due to the formation of pyrimidine dimers is at about 258 nm,        research indicates that various organisms are more affected at        other ranges of the UVC spectrum. Use of broad band UVC between        240 nm and 280 nm ensures that energy is delivered at        wavelengths that all organisms are susceptible to.

Pulsed light variants of polychromatic and UVC light also havegermicidal properties and offers advantages to the use of narrowband UVlight. These advantages include the following:

-   -   a. Laboratory data shows that high intensity pulses are        significantly more effective at penetrating tissue than when the        same amount of light energy is uniformly applied over a longer        period of time. Other research indicates that pulsing of high        energy light can increase the depth of penetration through        tissues by several orders of magnitude. This finding, which is        not common knowledge to those skilled in the art of treating        skin and other body disorders, permits the novel use of pulsed        light to inactivate organisms at a much lower dose of UVC than        continuously emitting light.    -   b. Since pulsed light can be more effectively used to penetrate        tissue and inactivate organisms it can substantially reduce the        time necessary for treatment.    -   c. Since pulsed light can be used to more effectively used to        penetrate tissue it can be used to treat infections that are        substantially deeper than surface infections.    -   d. Pulsed light emits significantly higher energy in a very        short time period compared with continuous light. These short,        high intensity pulses appear to overwhelm cells and damage vital        components, which are unable to dissipate the excess        instantaneous energy being applied. Additionally, short pulses        of light with longer periods of low or no light permit time for        energy to dissipate and thus limits the amount of heat that        surrounding tissues may experience which also limits collateral        damage    -   e. The very high peak of the energy pulse is often several        orders of magnitude greater than the average energy applied.        This high peak dose is more likely to exceed the threshold        energy (also called the energy of activation) that would drive        reactions that do not begin until this threshold is reached.        Thus, these peak doses can trigger reactions that will        contribute to the inactivation of organisms by damaging vital        components or forming compounds that are antibiotic in nature        such as singlet oxygen or ozone.    -   f. Pulsed light can damage undesirable cells with a lower        overall dose since it can deliver extremely high doses that        overwhelm the cell in short pulses with substantial periods        between each pulse. Thus an organism might experience a peak of        several orders of magnitude greater than if the light were        uniformly spread over time.

Coherent light variants of polychromatic and UVC light such as lasersalso have germicidal properties and offers advantages to the use ofnarrowband UV light. These advantages include the following:

-   -   a. Lasers can be pulsed to offer the same advantages that other        pulsed light sources possess, namely they can penetrate better        than continuous light.    -   b. All lasers make use of coherent light of a very narrow band,        which can thus be tuned to do the most damage to infectious        organisms while not affecting other organisms as greatly. For        example, if a particular organism is best deactivated at a        wavelength of 245 nm, a tunable laser could be used to deliver        light precisely at that wavelength. Surrounding tissue and        organisms would not be as greatly affected since most organisms        are affected most strongly between 258 nm and 262 nm.

4.12.2 Pulsed Polychromatic Light Dose Sufficient to Inactivate Microbes

While most wavelengths of light are not germicidal by themselves, theycan act synergistically to inactivate an organism. When combined withthe germicidal ability of UVC light, multichromatic sources can oftenlower the required dose of UVC by up to an order of magnitude or more.Xenon flash lamps are a particularly attractive source because inaddition to multiple wavelengths of light they can be pulsed to provideextremely high momentary doses of light and this light can be deliveredrepeatedly via a strobe mode. This can allow for greater applied lightdosage (“germicidal light at the source of the infection”) per amount ofgenerated light (“germicidal or other light as measured at the lightsource”). This has the following advantages:

-   -   a. High peak doses—very high peak doses can be delivered using        high energy pulses that have short durations. The overall energy        applied can still be lower on average than applied by a        continuous lamp, however, the peak doses could be 10 to        1,000,000 times or more than the average dose.    -   b. The high peak doses can act as a ‘punch’ to cause damage that        might not be accomplished at lower energies. An analogy would be        applying pressure to drive a nail through a piece of wood. If a        person pushed on a nail with his hand for days he may not be        able to drive a nail through wood. However, a strong momentary        blow to the nail delivered via a hammer can drive the nail        quickly. The total amount of energy applied by hand to the nail        could actually be greater but the momentary energy application        via a hammer is more likely to successfully drive the nail. In        the same way high peak doses have the ability to damage the        genetic material quickly and effectively without the use of high        average doses. Recent laboratory data indicate that the high        energy pulsed strobing of light can increase its ability to        penetrate tissue by several orders of magnitude.    -   c. Repetitive pulsating doses—a lamp that is pulsed, or strobed,        can deliver over one hundred intense pulses per second. These        pulses have the effect of rapidly changing the environment of        the organism and also affecting its biological processes. The        repetitive fluctuations can do damage that continuous light        might not accomplish. An example would be the flexing of a piece        of metal. While it might flex once or every a dozen times        without breaking, continuous flexing of a piece of metal will        cause it to fatigue and eventually break. With pulsed light, the        strobing of light at multiple pulses per second can effect this        type of fatigue and failure in an organism in a short period of        time. The strobing may also create harmonic waves which do        additional damage to the cellular processes of the organism.    -   d. Pulsing with very high voltage can shift the spectra of the        light to shorter wavelengths and dramatically increase the        amount of light emitted in the UV range which is also the        wavelength that is most germicidal.

4.13 Illustrations of Device to Prevent and Treat Skin and NailInfections

FIG. 4 illustrates a device to prevent and treat skin and nailinfections. The device may have any combination of the followingcomponents:

-   -   Light Source (10) that can be tuned to a specified spectral        output or a fixed spectral output.    -   A timer (12)    -   A means (14) to determine the intensity of the light    -   A processing unit (16) that can perform calculations, store        data, track usage, troubleshoot problems, etc.    -   A camera (18) to take pictures    -   A shield (20) to prevent light from illuminating other areas    -   Safety Labels (22)    -   Ground fault protector (24)    -   Safe Operating Instructions (26)    -   Security devices (28)    -   A connection (30) for special attachments

FIG. 5 illustrates some of the special attachments that could be usedfor treatment and includes the following:

-   -   a. An attachment (40) that can provide light to hard to reach        areas such as those between the toes.    -   b. An attachment that transmits light via a flexible cable (50)        and delivers this light at the end of the cable (52) to treat a        specific area.    -   c. An attachment that can be inserted in the mouth (60) and can        receive light from a flexible cable (62) that can transmit such        light.

5 PREFERRED METHODS OF USE OF INVENTION

As demonstrated in U.S. Pat. No. 6,960,201 (Cumbie), germicidal lightpenetrates nails and inactivates organisms to successfully cureinfections.

It has been shown that germicidal light can also be used to killorganisms and successfully treat skin and other tissue infections inparent application Ser. No. 11/154,707, filed on Jun. 18, 2005. The '707application also details a wide variety of germicidal light that can beused to kill and inactivate organisms which can also be used toinactivate and kill undesirable cells also. The '707 application furtherdetails methods to enhance the penetration and efficacy of germicidallight.

Additionally, although polychromatic light has been used to purify foodand water, it requires a significant amount of light in the UVB range,which would make it much less desirable to use on living humans oranimals since even low doses of UVB will cause sunburns. However,advances in thin films and other filtering technology have not beenconsidered by those skilled in the art of purifying food and water canfor filtering out UVB. The novel combination of broad band,polychromatic light with filtering of skin-damaging wavelengths permitsthe use of much higher doses of polychromatic light (that has beenfiltered to remove UVB) than have been previously contemplated. Itshould be noted that thin films that are applied to opticallytransparent material and other types of filters can be tuned so thatthey filter out any range of light that is deemed undesirable. Forexample, it may be desirable to filter out infrared and otherwavelengths to decrease the heat generated during treatment. Thus, lightcan be precisely tuned to have maximum effectiveness while minimizingundesirable side effects from unwanted wavelengths of light.

Light can also be channeled by a variety of devices to very specificapplication points. Light channels such as fiber optics that are capableof transmitting light in the UV range can be used to deliver UV light orpolychromatic light that is rich in UV to specific sites such as theinsides of body cavities such as the mouth, the esophagus, the lungs,stomach, anus, ears, etc. These light channels can also be used todeliver light to internal parts of the body such in a similar mannerthat a catheter can be used to pierce an organ or tumor. Additionally,the light channels themselves could be used as observation ports inaddition to being used to deliver light to the selected target area.

Germicidal light can also be used similarly for the treatment of animalswith various disorders. This could be done for both domesticated animalsand others. In particular, animals that have diseases of nails or hoovesand animals that have similar disorders to humans would great benefitfrom this type of treatment.

Germicidal light can also be used for organs that will be transplanted.Use of this light for organs will reduce the chance for infection andalso the chance for rejection by the body. The inactivation of surfacecells and organisms makes the possible rejection by the recipient bodymuch less probable. In some embodiments, the germicidal light can beapplied before removal of the organ from an organ donor. In someembodiments, the germicidal light can be applied after removal of theorgan from an organ donor, but before inserting into an organ recipient.In some embodiments, the germicidal light can be applied after insertioninto an organ recipient.

Germicidal light can be used to kill and inactivate organisms that causedisease, infections, and disorders in a similar manner. Examples ofthese categories includes warts, boils, strep infections, athlete'sfeet, eczema, cold sores, etc. These examples are not intended to becomprehensive but are only illustrative of how one skilled in the artsuch as a dermatologist could successfully apply this invention.

Germicidal light can be used to inactivate and kill undesirable cells byapplying such light to the area or volume to be treated. Areas that areoutside the targeted treatment area should be shielded from the lightbeing used in treatment to prevent damage to healthy, desirable cells.

Germicidal light can best be used when the characteristics of the areato be treated are known with relation to the kind of light beingtreated. For example, if it is known that germicidal light at 254 nm canpenetrate fair skin with an infection up to 1 mm when applied at astrength of 25 mw/cm2 for 10 minutes then this light can be used totreat superficial skin infections. However, if a cancerous tumor with adepth of 5 mm is to be treated it may be necessary to use a germicidallight source that can penetrate more deeply. For example, it may be bestto use a 100 nanosecond pulse of polychromatic light that is rich in UVCand is generated by a xenon pulse lamp if it is known that this kind ofgermicidal light can penetrate a cancerous tumor to a depth of 5 mmeffectively.

5.1 Treatment of Cancer

Research by Silvano Nocentini (Apoptic Response of Malignant RhabdoidTumors Cells, published in 2003 in Cancer Cell International) notes thatapoptosis can be induced in malignant rhabdoid tumor cells with doses ofUVC as low as 20 J/m² (2 mj/cm²), which is similar to the dose that caninactivate many disease causing organisms. It is likely that other typesof cancerous cells have a similar propensity to initiate apoptosis atsimilar dosages given the common characteristics that these types ofcells share such as similar membrane thicknesses and genetic material.However, these findings and others like them have not stimulated thedevelopment of treatments for cancer based on using UVC and othergermicidal light since it is believed it cannot penetrate deeply enough.Additionally, the paradigm shift required use something potentiallycarcinogenic itself to cure cancer has also prevented its application.These impediments to developing an effective cancer treatment have beendiscussed in other places in this application. It is enough to say herethough that such light can be used successfully. It is recommended thatone or more of the following preferred procedures be implemented tosuccessfully treat cancer:

-   -   a. determine what dosage is necessary to inactivate the cell        that is undesirable;    -   b. determine the depth the light must penetrate to reach all        cells that are to be treated;    -   c. determine how much the light used for treatment will        attenuate for said light to penetrate to the necessary depth;    -   d. determine the most appropriate type of light for said        treatment with continuous UVC light for more shallow treatments        and wide spectrum pulsed light for deeper treatments;    -   e. determine the necessary dose of light to apply taking into        account the above factors and adding a factor of safety to the        calculations.; and/or    -   f. apply the necessary dose of light to treat the cells.

For example, if it was desired to treat a melanoma skin cancer tumorthat was 1 mm deep it would be possible to use a continuous UVC lighttherapy, however, a wide spectrum pulsed light would be preferable dueto its ability to penetrate more deeply. If the melanoma tumor wouldinitiate a apoptosis at a UVC dose of 2 mJ/cm² of wide spectrumgermicidal light it would still be preferable to use the wide spectrumlight due to its ability to penetrate better and because such light isgenerally well tolerated. If 0.1% the wide spectrum light couldpenetrate to the bottom of the tumor the necessary dose would be 2,000mj/cm² (2 J/cm²). However, this high dose of UVC can be well toleratedparticularly if the light is pulsed and it should be noted that thesurrounding skin will be fully covered (“shielded”) so only theundesirable cells will be exposed to this magnitude of light. To applythis light, a practitioner could use a xenon flash bulb capable ofdischarging 0.1 mj/cm² of UVC per flash. This would thus require 20,000flashes to treat the area. If lamp emitted 50 flashes per second thetotal treatment time would be 400 seconds or 6 minutes and 40 secondstotal. Adding a factor of safety of 50% would bring total treatment timeto 600 seconds or 10 minutes total.

It should also be noted that in the above example, a very high amount ofUVB would also be present and applied. If only the tumor was exposed andno surrounding skin was exposed it would not be necessary to filter outthe UVB and the UVB might have actually have a synergistic effect andincrease the efficacy of the treatment. However, if a large amount ofsurrounding skin were exposed, it might be advisable to filter out theUVB light to prevent a painful reaction and possible blistering.

5.2 Treatment of Psoriasis 5.2.1 Summary of Psoriasis

Psoriasis is an autoimmune disease of the skin which affects 2% to 3% ofthe population worldwide. According to the National Institute of Health,between 5.8 and 7.5 million Americans are affected by psoriasis.Americans spend between $2 to $3 billion each year to treat psoriasisaccording to the National Psoriasis Foundation.

There are five types of psoriasis—plaque, guttate, inverse, pustular,and erythrodermic. Plaque is the most common form of the disease andappears as raised, red patches or lesions covered with a silvery whitebuildup of dead skin cells, called scale. About 80% of those affectedhave plaque psoriasis. Guttate appears as small red spots on the skin.Inverse occurs in armpits, groin and skin folds. Pustular manifests aswhite blisters surrounded by red skin. And erythrodermic has intenseredness over large areas.

Research indicates that psoriasis is an immune-mediated condition. Thismeans the condition is caused by faulty signals in the body's immunesystem. It is believed that psoriasis develops when the immune systemtells the body to over-react and accelerate the growth of skin cells.Normally, skin cells mature and are shed from the skin's surface every28 to 30 days. When psoriasis develops, the skin cells mature in 3 to 6days and move to the skin surface. Instead of being shed, the skin cellspile up, causing the visible lesions.

Psoriasis cases are classified as mild (less than 2% of the body'ssurface area affected and usually localized on the knees, elbows, scalp,hands and feet), moderate (between 2% and 10% coverage usually appearingon the arms, legs, torso and head), and severe (greater than 10%coverage and potentially involving all areas of the skin) Even a smallamount of body cover such as 2% can be significant if that area isespecially sensitive such as the hands or feet. An estimated 80-85% ofpsoriasis cases are mild to moderate. Psoriasis is rarelylife-threatening, however, a person's quality of life can be seriouslydegraded. Additionally, there is a high economic cost to bothindividuals and the country since it causes an estimated 56 million losswork hours each year.

Dermatologist us the PASI scale (Psoriasis Area and Severity Index) todetermine the severity of the disorder in individuals. PASI is acomposite measure of erythema (redness), induration (plaque thickness),and desqamation (scaliness). The scale ranges from 0 (clear) to 72 andis calculated for an affected area and then multiplied by the amount ofcoverage on a individual. Clinicians and practice dermatologists oftendevise their own “modified PASI,” a scoring system that best meets theirdescriptive needs, and clinical papers always describe how a particulartrial's PASI is calculated. For instance, while a patient may have only2% coverage, if it is on the feet and the patient cannot walk, aphysician would score this condition higher than a non-debilitatingsimilar-sized plaque on the trunk area. The percent decrease in PASIscore is the commonly accepted measure of the efficacy of psoriasistreatments, with a 75 percent decrease in PASI score (PASI 75) viewed asa clinically significant outcome.

Psoriasis can be treated with topical medications, oral medications,and/or with phototherapy. There are hundreds of over-the-counter topicalmedications that are used, however, these cannot be used continuouslyand provide at most temporary relief. Treatment with steroids is morepowerful and effective. However, use of steroids is expensive and theiruse must be carefully monitored and applied. If steroid therapy isabruptly stopped, it can cause severe problems which can be lifethreatening. Long-term steroid use can lead to tachyphylaxis—loss ofeffectiveness. As steroids pass into the blood stream, systemic sideeffects can include high blood pressure, cataracts, glaucoma,hypothamic-pituitary-adrenal axis suppression, manifestations ofCushing's Syndrome, diabetes, and growth of body hair on women. Whilenot conclusively proven, there is concern that long-term corticosteroiduse may hasten the onset and severity of osteoporosis.

Non-steroidal topicals such as vitamin D analogs were introduced to theU.S. market in the early 1990s. Vitamin D analogs inhibit proliferationof skin cells and act to reduce inflammation. Clinical data for thetreatment of mild to moderate chronic plaque psoriasis showed a meandifference in the percentage change in PASI score of 44%, similar toClass 2 steroids, but it may take two months to achieve this benefit,not the several weeks for steroids. Non-steroidal topicals do not havethe serious side effects associated with steroids.

Systemic agents include antimetabolite drugs (methotrexate) andimmunosuppressives (cyclosporine). Systemic drugs are used for the moresevere forms of psoriasis and show good results—70% to 80% of patientsshow 75% improvement and clearing is frequent; however, their toxicitylimits their usage. Cyclosporine is a powerful immunosuppressant whosemajor application is in organ transplantation to prevent rejection of atransplanted organ by the body's immune system. While highly effective,cyclosporine has a broad range of systemic side effects that may involvethe gastrointestinal system, the kidneys, lungs, musculoskeletal system,reproductive system and increases risk of lymphoma and other cancers.

In addition to the above treatments, UVA and UVB phototherapy is alsowidely used to treat psoriasis. Plaque psoriasis responds positively toUV light and exposure to sunlight has long been known to be therapeutic.There are two frequency spectra of UV that penetrate the atmosphere: UVBfrom 290 to 320 nanometers (nm) and the longer frequency UVA—320 to400-nm. So-called “broad band” UV therapy was developed at the MayoClinic in the 1920s, the start of light booth therapy where UV-emittingbulbs are arrayed in a booth in which the patient stands. Phototherapyhas since been refined into two categories.

UVA: The longer waves of UVA penetrate the skin more deeply than UVB andrequire a photosensitizing agent to be effective in treating psoriasis,psoralen, a drug usually taken orally, but can be applied topically orby immersion. Psoralen+UVA=PUVA. The combined photosensitizer and UVAenergy inhibit DNA synthesis in skin cells and suppress the skin cellproliferation of psoriasis. Treatments are repeated two or three times aweek and it takes about 30 to 40 treatments for full effect. Once thepsoriasis has improved about 95%, the patient starts weekly treatmentswhich gradually become less frequent until they are administered onlyfor flare ups.

For moderate to severe patients PUVA is generally very effective,typically an 85% decrease in PASI is achieved, and once a patientreaches remission results are long lasting, roughly six months orlonger. However, as psoralen also affects the retina, patients arehighly sensitive to light for hours after the drug is taken, use ofwrap-around sunglasses for 24 hours post-treatment is recommended, andadditional side effects can include nausea (common), itching, andincreased risk of cataracts. White spots commonly develop wherepsoriasis plaques had occurred, particularly in people with naturallydarker skin. A longer term risk stems from the fact UVA penetrates theskin more deeply than UVB, so there is a greater danger of deep skindamage and accelerated skin aging. It has been known for some time thatPUVA can modify DNA and cause genetic mutations. PUVA is known toincrease the risk for squamous cell skin cancer and slightly increasethe risk for basal cell skin cancer, both of which, however, are nearlyalways curable. There is increasing concern of the long term increasedrisk of melanoma, a serious cancer, particularly in people who receivemore than 250 treatments. Those favoring continued use of PUVA arguethat it is a most effective treatment for severe psoriasis, thealternatives are usually very powerful drugs which have even moreserious side effects.

Much research has concentrated on the so-called antipsoriatic rangewhich lies between 300 to 313-nm. Therefore, most UVB treatments forpsoriasis concentrate their output in the 300-313-nm range (also callednarrow band UVB). In the late 1980s, Philips developed the “narrow band”TL-1 UVB bulb with a frequency output curve that peaks at 312-nm anddelivers 73% of its energy into the antipsoriatic range with fairlytight distribution “tails.” Erythema (sun burning) is caused by low-endUVB frequencies peaking at 295-nm and erythema is associated withmutagenic cellular response. Since NB-UVB packs most of its energy intothe antipsoriatic range, fewer treatments are required than broadbandUVB and PUVA to achieve remission. On the negative side, NB-UVBremission times are not as long as PUVA. An examination of theliterature by MDs John Koo and Mark Lebwohl published in 1999 showed 42%of PUVA patients who maintained their maintenance regimen were stillclear after one year whereas 83% of UVB patients relapsed by 6 months,relapse being defined as recurrence of 3% or more of body surface areaof psoriasis than when the patient was clear. This study also notedmaintenance UVB at least once a week cut the relapse rate to half.

5.2.2 Use of Germicidal Light to Treat Psoriasis

As noted earlier, psoriasis is a condition where the body produces anoverabundance of skin cells that quickly migrate to the skin's surface.It is believed that this disorder is an autoimmune reaction and that itis mediated by T cells. Additionally, the basal cells in the epidermisproduce an overabundance of keratinocytes (immature skin cells) which inturn produce a large amount of keratin, which is a tough fibrous proteinthat help form hair, skin, and nails. In normal cell growth,keratinocytes mature and migrate from the bottom (basal) layer to thesurface and are shed unobtrusively over a period of about a month. Inpsoriasis the keratinocytes proliferate very rapidly and travel from thebasal layer to the surface in only about four days. Because the skincannot shed these cells quickly enough they accumulate in thick, drypatches, or plaques. Another important change occurs in the layer ofskin underneath the epidermis which is called the dermis and whichcontains nerves and blood and lymphatic vessels. In psoriasis theseblood vessels provide an increased blood supply to the abnormallymultiplying keratinocytes, causing the underlying inflammation andredness characteristic of psoriasis.

Thus, psoriasis is mainly a disorder of the epidermis, which isapproximately 10% of the thickness of skin overall. The remaining 90% ofthe skin is the dermis. The epidermis is generally about 0.12 mm thickin most areas although this value varies among individuals and differentparts of the body (the hands and feet being the thickest at 1.5 mm andonly 0.05 mm at the eyelids). Therefore, since the epidermis is not verythick, it is possible to effectively treat psoriasis using light thatdoes not penetrate easily.

Thus UVA and UVB have been used to treat psoriasis with some success.However, UVC has not been used to treat psoriasis for a number ofreasons as discussed below.

First, UVC penetrates much less deeply than UVA or UVB. While UVA canpenetrate through the epidermis and deeply into the dermis and UVB canpenetrate the epidermis and part of the dermis, most literature teachesaway from UVC, indicating that UVC can only penetrate the part of theepidermis and does not reach the dermis at all (source: WHO InterSunproject). However, our research with nails confirms that the penetrationof UVC appears to be understated and that although most UVC cannotpenetrate the full depth of the epidermis and into the epidermis, smallamounts can penetrate and those amounts are sufficient to treatpsoriasis and other disorders and infections.

Second, although UVC cannot penetrate very deeply, there are ways toenhance penetration such as by pulsing the light or adding a topicaltreatment to enhance penetration. In addition, multispectrum light canalso be used to enhance penetration and to add synergistic light bands.

Third, most people skilled in the art of phototherapy with UVA and UVBdo not understand that UVC is very well tolerated in dose far in excessof the minimum erythemal dose (MED). Even doses in the range of 100 MEDswill only turn the skin red—it will not be accompanied by the pain of asunburn that even 5 MED doses of UVB can cause. The reason that UVC isso well tolerated may be because it does not penetrate well and thusmostly affect the dead cells at the top of the skin. However, that isactually an advantage when trying to treat psoriasis since this is oneof the primary problem areas.

Fourth, most practitioners of phototherapy do not realize just how smalla dose of UVC can be is effective. Doses in the low mj/cm² range caninactivate organisms and cells. Thus, it is not necessary to apply high,lethal doses of UVC to cells or organisms to successfully treat them.

Fifth, some practitioners are concerned that UVC may be carcinogenic.Although there is evidence of this, it should be noted that it isgenerally chronic exposure that is the most dangerous. However, thischronic exposure is not contemplated for treatment. Additionally itshould be noted that UVA and UVB are both considered as carcinogenic asUVC, and they are regularly used in phototherapy since it is perceivedthat the benefits of treatment outweigh the potential risks.

Sixth, the literature teaches away from the use of UVC to treatpsoriasis. For example, research was published as “Action Spectrum forthe Treatment of Psoriasis” by Dr. Parrish in 1981 in the Journal ofInvestigative Dermatology. The research concluded that UVC wasineffective in treating psoriasis. However, several items should benoted. The first is that the maximum dosage of UVC applied was 1 J/cm²which is about 50 MED. However, it is possible to apply significantlymore UVC without serious side effects. Additionally, it should be notedthat the sample was small—only four individuals. There is also apossibility that the filter used on the low pressure mercury lamp (thesource of UVC for the test) may have decreased the effectiveness of theUVC being applied. Finally, it should be noted that only one bandwidthof UVC was used (254 nm) while the UVC range extends from 240 to 280 nm.It is probable that another wavelength within the UVC range would haveelicited a much better response.

Thus, although researchers and practitioners have not used UVC fortreatment of psoriasis and other disorders, there are a number ofreasons that make it attractive. These reasons include the following:

-   -   a. UVC light generally only affects the epidermis and should        cause little damage to the dermis. Even if the penetration of        UVC is enhanced (for example by using UVC-rich pulsed        polychromatic light) it will still not penetrate as deeply as        many other wavelengths thereby limiting damage to deeper        tissues.    -   b. Psoriasis is primarily a disorder of the epidermis. Thus UVC        can effectively penetrate the area necessary to treat psoriasis,        and since it does not penetrate more deeply, it does not elicit        the painful burning reaction that UVB does. The use of screening        to block application of light to only the affected (“scaling”)        also reduces undesired side effects, while “killing” the        targeted cells.    -   c. UVC light is far more potent than other wavelengths of light        with respect to its ability to inactivate and kill cells and        organisms. Thus the dosage of UVC can be much less than would        otherwise be required.    -   d. The application of UVC can be enhanced by pulsing of the        light to permit it to penetrate more deeply and to permit        smaller doses to be applied. If wideband polychromatic light is        used to generate the UVC, undesirable wavelengths such as UVB        can be filtered out or minimized to optimize treatment. However,        if the only area being exposed has thick plaque it may be        acceptable to not filter out the UVB light.    -   e. Application of germicidal light that includes UVC and that        penetrates more deeply can also inactivate the basal cells that        create an overabundance of keratinocytes thus relieving a major        problem. It may also affect the T Cells that may be mediating        the problem.    -   f. There are data that indicate that psoriasis vulgaris is        mediated by activated T-lymphocytes infiltrating the epidermis        and the dermo-epidermal interface. UVC can be used to treat        psoriasis by infiltrating T-cells and inactivating them, where        the mechanism of cell death is most probably apoptosis or damage        to genetic material, which prevents the cells from reproducing.

The above reasons are illustrative and not comprehensive. They serve toshow that treatment of psoriasis using germicidal light can be veryattractive and effective.

5.2.3 EXAMPLE 3 Using Germicidal Light to Treat Psoriasis

A recent external study of patients affected by plaque psoriasisindicated that the thickness of the epidermis averaged approximately 550um compared to 212 um for those unaffected by psoriasis. It is notnecessary to penetrate the full depth of the plaque (with screening asnecessary to protect surrounding tissue) to successfully treatpsoriasis, however, treatment that does penetrate more deeply is morelikely to be more effective and to also require less follow uptreatment.

Testing of UVC ability to penetrate nails by the applicant indicatesthat UVC can penetrate to a depth of 550 um, however, it should be notedthat only a very small amount of unconditioned UVC will penetrate tothat depth. However, broadband pulsed light can be used to successfullypenetrate this depth with a much higher dose of UVC than could bedelivered by a narrowband, continuous emitting low pressure mercurylamp. Therefore, this type of light would be the preferred mode oftreatment.

Although there are certain cells and organisms that are significantlymore difficult to inactivate due to their spore forming ability, etc.,most cells and organisms are inactivated with a UVC-rich polychromaticlight dose in the range of 10-40 mj/cm² total UVC dose. Since it isprobable that only about 0.5% of the light will penetrate to thenecessary depth it would be necessary to apply 200 times the dose thatwill inactivate organisms on the surface, or a dose of 2000 to 8000mj/cm² of UVC. Approximately 10% of a highly pulsed xenon lamp is UVC,therefore, total energy dose applied would be 20 to 80 J/cm² totallight. Data indicate that this dose can be tolerated by skin withoutdiscomfort. However, a similar amount of UVB will also be delivered andif this amount of light irradiates normal skin it will cause painfulburns. Therefore, it would be desirable to filter out all UVB from thelight to be applied. Alternately, a narrowband UVC light can be used andthere will be no need to filter out the UVB. Preferably the narrowbandUVC light will be highly pulsed such as that generated by a laser.

5.2.4 Additional Notes on Use of UVC to Treat Psoriasis

UVC can be used with PUVA to treat psoriasis. This would permit thesynergistic use of these treatments which would lower the dose of eachtreatment individually.

UVC can be used with UVB and/or UVA to treat psoriasis. Again this wouldpermit the combination of therapies so that doses of each individualtherapy could be reduced and synergistic results obtained.

Alternating and/or combining treatment using UVC along with at least oneother treatment selected from a group including wideband UVB, narrowbandUVB, UVA, PUVA, topical treatments, and oral medications are othermethods to treat psoriasis.

5.3 Other Types of Treatment

Additionally, germicidal light can be provided to a specific locationusing a light guide which can also act as a scope to view the area. Thelight guide could be inserted remotely in a mass of tissue such as atumor and then used to irradiate the mass with germicidal light. Thiswill permit the inactivation and destruction of cells that are creatingundesirable conditions.

Germicidal light could be introduced to the nasal cavity of a person andused to inactivate mast cells or other cells that trigger an allergicreaction. This form of treatment could be used to prevent severeallergies in a person who has an overactive immune system

Germicidal light could also be introduced using a light guide to thethroat to treat yeast infections, which often occur when food andbreathing tubes are inserted. Specially designed breathing and foodtubes could transmit the light (and are claimed as part of thisinvention) or the light could be introduced using a separate instrument.

Germicidal light could be used to treat warts. Although they are moredifficult to treat due to their thickness, germicidal light can beapplied in high doses and/or light that is more penetrating could beused.

Ringworm and other skin infections could be treated using germicidallight with the dosage being adjusted to penetrate the infectionsufficiently. Techniques to lessen the thickness of the area to betreated can be used to enhance treatment such as scrubbing of thesurface, abrading the area, etc. Additionally, topically appliedtreatments such as antibiotics could be used in conjunction with lighttreatment to enhance the treatment's efficacy.

Organisms that have become resistant to almost all antibiotics are anideal candidate to be treated using this invention. Light dosage must beadjusted to ensure correct penetration and other techniques mentioned inthis application to enhance efficacy can also be used.

All forms of cancer can be treated using this invention, however, themost effective treatment will occur when the mass to be treated is welldefined and not too large. If the mass is large, multiple treatments ormultiple points of treatment may be required. For treatment of a lumpsuch as that in breast cancer, the device can be inserted in the middleof the mass and large amount of germicidal light be used. It should benoted that it should not be necessary to screen out UVB during this typeof treatment since it should not create painful blistering. On thecontrary UVB along with other synergistic wavelengths should improvetreatment tremendously. Additionally, longer wavelengths of light cancause significant heating of the mass, which would be detrimental to itsviability. By monitoring the temperature immediately outside the mass(by thermal imaging or probe) it should be possible to add large amountsof heat to damage the mass without sustaining permanent damage to themass.

Germicidal light can be used to treat ulcers, warts, acne, cold sores,and other infections, diseases, and disorders that are caused byundesirable organisms or cells. It can also be used to amelioratesymptoms that include the presence of undesirable cells or organisms.

Wounds have been treated with monochromatic UVC (Johnson Patent U.S.06/283,986), however, this treatment consisted only of surface treatmentsince the amount of UVC used was very low and was modified to penetratemore deeply. This application claims the use of modified germicidallight (whether pulsed, wideband, and/or otherwise modified) to treat allkinds of wounds including bed sores, lacerations, ulcers, and epidermaltrauma. Use of enhanced germicidal light would permit greatly enhancedtreatment of wounds since it would permit inactivation and/or killing oforganisms that are not on the surface, i.e. organisms that aresubcutaneous or are otherwise shield from direct light.

Similar methods can be used to inactivate and kill organisms that causedisorders, diseases, and infections.

5.4 Dosages to be Applied During Treatment

A wide variety of dosages may be applied to prevent or treat skin andnail infections and disorders and to inactivate organisms and tissuethat are undesirable.

For the treatment of nail infections, using the application ofmonochromatic UVC light has been shown to be efficacious in doses assmall as 37 mj/cm² per treatment, see for example Cumbie U.S. Pat. No.6,960,201, and as high as 22 J/cm² (as noted in this application).Additionally, these doses are well tolerated by the subject nailsreceiving the treatment. Allowing for smaller doses to be used forprevention of nail infections and for somewhat higher doses for severelyinfected nails, the applied dosage of UVC may be between approximately10 mj/cm² and 50 J/cm² per treatment. The number of treatments may varyfrom 1 to 10 or more depending on the level of infection.

For treatment of nail infections using the application of modified UVClight (modified germicidal light using wide spectrum light, pulsing,etc.) the dose could be from 1% to 100% of the UVC that would berequired using monochromatic UVC listed above. Thus applied dosages ofUVC using modified germicidal light would be between 0.1 mj/cm² and 10J/cm² of UVC light (not including other bands of light applied).Specifically, the amount of UVC provided by a xenon pulsed lamp has beenshown to be efficacious when applied in the range of approximately 1900mj/cm² per treatment for mild to moderate nail infections. Thus a rangeof approximately 500 mj/cm² to 8,000 mj/cm² of UVC delivered via apulsed xenon light could be especially efficacious to treat many typesof nail infections. The number of treatments may vary from 1 to 10 ormore depending on the level of infection.

Treatment of skin and other tissue would fall in the same ranges listedabove, however, for purely surface infections such as athlete's foot,this dosage could be even lower since it would not need to penetrate asdeeply.

The above dosages are based on data of efficacious treatment ofinfections. One skilled in the art of assessing infections and disorderscan apply these guidelines to deliver the correct dosage necessary toeffectively prevent and treat skin and nail disorders and infections andinactivate cells or tissue that are undesirable.

6 FURTHER PREFERRED EMBODIMENTS

A further preferred embodiment of the invention would be to usegermicidal light that has been enhanced to better penetrate andinactivate and kill undesirable cells. This light can be enhanced byhigh strength, short pulses of light that are generated by a widespectrum light device like a xenon flash lamp. In one preferredembodiment the light would be polychromatic light that is rich in UV(especially UVC) and would be high strength (up to several Joules) andhighly pulsed (multiple pulses per second such as the 120 pulses persecond of some xenon flash lamps). In another preferred embodiment areduced number of pulses would be used but each pulse would have asubstantially higher peak dosage. This would increase the magnitude ofenergy available to exceed the energy of activation for processes thatwould damage or destroy the cell or organism while not increasing theaverage total dose delivered.

In another preferred embodiment the light would be monochromatic asgenerated by a laser. The laser would be tuned to provide the mostgermicidal light while minimizing discomfort and would also delivershort, high pulses of light.

Another preferred embodiment of the invention would be to usemonochromatic germicidal light such as a low pressure mercury or anamalgam lamp that can provide substantial light to the area to betreated. Although this light would not penetrate as deeply asconditioned germicidal light it can be used for disorders that are notas deep as other disorders such as psoriasis, ringworm, or types of skincancer that do not penetrate as deeply.

Another preferred embodiment of the invention would use filters or othermeans to remove unwanted bandwidths of light. This would be especiallyof use for treatments of disorders such as psoriasis where the use ofUVB for treatment can cause painful burns.

Another preferred embodiment of the invention would be to use it for thetreatment of animals.

Another preferred embodiment of the invention would be to use it for thetreatment of organs to be used for transplant. Flash irradiation of theorgan could decrease the potential for organ rejection as well aslowering the chance of infection.

6.1 Illustrative Germicidal Light Generators

A number of lights can be used to generate germicidal light. The listcontained herein is intended to be illustrative and not exhaustive. Oneskilled in the art could use similar devices to generate light and suchdevices are claimed in this application.

Means to generate germicidal light include the following:

-   -   a. Polychromatic light sources, that generate either pulsed and        continuous or both.    -   b. Light Emitting Diodes which are available in a number of        spectrums including ones recently developed that emit in the UVC        range.    -   c. Pulsing and Continuous Excimer Lamps including xenon-iodine        (XeI or also designated as XeJ) excimer lamps emits most of its        light at 253 nm, chlorine (Cl—Cl) excimer lamps emit at 258 nm,        xenon-bromine (XeBr) emit at 283 nm (while this is just outside        the UVC range it still have the potential to be very        germicidal), xenon lamps, etc.    -   d. Pulsed lamps that can emit extremely strong pulses. There is        evidence that it is more efficacious to have several very strong        pulses instead of a number of smaller pulses. Time between the        pulses can also be a significant factor and should thus be        optimized.    -   e. Other light sources such as lasers, mercury vapor lamps,        lamps that contain mercury with other elements, etc.

7 SUMMARY, RAMIFICATIONS, SCOPE

Germicidal light can be used to inactivate and kill undesirable cellspermitting it to be used to treat a wide range of disorders includingcancer, tumors, autoimmune disorders such as psoriasis, etc. This typeof light has not been considered in the past for this type of treatmentbecause the primary form of germicidal light which is UVC cannot easilypenetrate objects and can be carcinogenic. However, UVC and other formsof germicidal light to penetrate can be enhance to improve its efficacy.Also, the possibility of germicidal light causing cancer can beminimized by preventing chronic exposure.

All references and patents identified or discussed herein are expresslyincorporated by reference. To the extent that such references andpatents conflict with this application, the instant specificationcontrols.

1. (canceled)
 2. A method of treating at cancer comprising applying adose of electromagnetic radiation that has a substantial component in awavelength less than 280 nm capable of directly altering the DNA or RNAof cancer cells and destroying the cancer cells by geneticide.
 3. Amethod of treating at least one of warts, boils and ringworm comprisingapplying a dose of electromagnetic radiation in a wavelength less than280 nm capable of directly altering the DNA or RNA of the wart, boil orringworm and destroying the wart, boil or ringworm cells by geneticide.4. A method of treating autoimmune disorders comprising applying to theepidermis of a patient a dose of electromagnetic radiation in awavelength less than 280 nm capable of directly altering the DNA or RNAof epidermal cells, wherein the dose of electromagnetic radiationdestroys scales in the epidermis by geneticide. 5-39. (canceled)